The Heartland Study

Sponsor

Heartland Health Research Alliance (Other)

Overall Status

Recruiting

CT.gov ID

NCT05492708

Collaborator

Indiana University School of Medicine (Other)

2,600

Enrollment

Locations

107.7

Anticipated Duration (Months)

866.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Heartland Study is a prospective, observational study that will enroll up to 2,600 pregnant participants across the Heartland States in the U.S..

The objective of the Heartland Study is to address major knowledge gaps concerning the health effects of herbicides on maternal and infant health. The study is being conducted to evaluate the associations between environmental exposures to herbicides during and after pregnancy and reproductive health outcomes. The study is measuring multiple biomarkers of herbicide exposure among pregnant Midwesterners and their partners to evaluate associations with pregnancy and childbirth outcomes, epigenetic biomarkers of exposure, and child development.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related Pregnancy Complications Birth Defect Gestational Age and Weight Conditions Spontaneous Abortion Miscarriage Exposure to Herbicides

Detailed Description

During Phase 1 of the Study, newly pregnant mothers will be enrolled less than or equal to 20 weeks + 6 days gestation and followed through to the end of pregnancy. Prenatal urine and buccal (cheek) samples will be collected to measure urinary herbicide exposure levels and to identify herbicide induced epigenetic biomarkers. Pregnancy outcomes and fetal health will be documented and analyzed to further investigate potential effects of fetal exposure. Indirect measures such as food and beverage consumption, workplace and household related chemical exposures, substance use, residential proximity to agricultural fields, and socioeconomic factors will be captured from questionnaires.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Children's Health in the Heartland Study

Actual Study Start Date :

Jan 11, 2020

Anticipated Primary Completion Date :

Jan 1, 2027

Anticipated Study Completion Date :

Jan 1, 2029

Outcome Measures

Primary Outcome Measures

Pregnancy loss [Enrollment to birth]
Number of participants who experience a pregnancy loss
Preterm birth [Enrollment to gestational age 36 +6]
Number of births that occur between gestational age 20 +0 and 36 +6
Hypertensive disorders of pregnancy [Enrollment to up to twelve weeks after delivery]
Number of participants diagnosed with a hypertensive disorder of pregnancy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Pregnant persons ages 18 or older at time of consent who are ≤20+6 weeks pregnant. Best clinical estimate of gestational age will be utilized for recruitment purposes. Enrollment in the first trimester (≤ 13 + 6) is preferred, but anyone ≤ 20 +6 is permitted.
Living in one of the 13 Heartland Study region states at the time of enrollment (Arkansas, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, or Wisconsin) Optional inclusion of the putative biological father

Exclusion Criteria:

Participants who are not fluent in and/or do not fully understand, read, write, or speak the English language.
Other inability to provide informed consent to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Medical Center	Indianapolis	Indiana	United States	46202
2	Franciscan Health Indianapolis	Indianapolis	Indiana	United States	46237
3	Gundersen Health	La Crosse	Wisconsin	United States	54601